Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-29 @ 3:13 AM
Study NCT ID:
NCT04556734
Status:
COMPLETED
Last Update Posted:
2024-06-26
First Post:
2020-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Oral Etrasimod in Adult Participants With Moderate-to-Severe Alopecia Areata
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000506', 'term': 'Alopecia Areata'}, {'id': 'D000505', 'term': 'Alopecia'}], 'ancestors': [{'id': 'D007039', 'term': 'Hypotrichosis'}, {'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000656249', 'term': 'etrasimod'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)', 'description': 'Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.', 'eventGroups': [{'id': 'EG000', 'title': 'DB Treatment Period: Etrasimod 2 mg', 'description': 'Participants who were randomized to receive etrasimod 2 milligram (mg) orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 11, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'DB Treatment Period: Etrasimod 3 mg', 'description': 'Participants who were randomized to receive etrasimod 2 mg orally once daily initially for Week 1 and then etrasimod 3 mg orally once daily for rest of the 23 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 12, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'DB Treatment Period: Placebo', 'description': 'Participants who were randomized to receive placebo matched to etrasimod orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 11, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'OLE Period: Etrasimod 2 mg [Etrasimod 2 mg in DB Treatment Period]', 'description': 'Participants who received etrasimod 2 mg in DB treatment period, received etrasimod 2 mg orally once daily in OLE period.Participants were followed up for up to 4 weeks after last dose of study drug.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 3, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'OLE Period: Etrasimod 2 mg [Placebo in DB Treatment Period]', 'description': 'Participants who received placebo matched to etrasimod in DB treatment period, received etrasimod 2 mg orally once daily in OLE period.Participants were followed up for up to 4 weeks after last dose of study drug.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 2, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'OLE Period: Etrasimod 3 mg [Etrasimod 3 mg in DB Treatment Period]', 'description': 'Participants who received etrasimod 3 mg in DB treatment period, received etrasimod 3 mg orally once daily either from Week 25 to Week 52 or beginning after Week 25 to Week 52 in OLE period. Participants were followed up for up to 4 weeks after last dose of study drug.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 14, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'OLE Period: Etrasimod 3 mg [Etrasimod 2 mg in DB Treatment Period]', 'description': 'Participants who received etrasimod 2 mg in DB treatment period, received etrasimod 3 mg orally once daily either from Week 25 to Week 52 or beginning after Week 25 to Week 52 in OLE period.Participants were followed up for up to 4 weeks after last dose of study drug.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 11, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'OLE Period: Etrasimod 3 mg [Placebo in DB Treatment Period]', 'description': 'Participants received placebo matched to etrasimod in DB treatment period, received etrasimod 3 mg once daily either from Week 25 to Week 52 or beginning after Week 25 to Week 52 in OLE period.Participants were followed up for up to 4 weeks after last dose of study drug.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 11, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Gamma-glutamyl transferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Supraventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': "Fuchs' syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Electrocardiogram abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Tri-iodothyronine free increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Retinal migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Menstruation irregular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Postmenopausal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hypopnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'seriousEvents': [{'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Myelopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Severity of Alopecia Tool I (SALT I) at Week 24: DB Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Treatment Period: Etrasimod 2 mg', 'description': 'Participants who were randomized to receive etrasimod 2 milligram (mg) orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'DB Treatment Period: Etrasimod 3 mg', 'description': 'Participants who were randomized to receive etrasimod 2 mg orally once daily initially for Week 1 and then etrasimod 3 mg orally once daily for rest of the 23 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'DB Treatment Period: Placebo', 'description': 'Participants who were randomized to receive placebo matched to etrasimod orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.79', 'spread': '8.557', 'groupId': 'OG000'}, {'value': '-21.43', 'spread': '6.926', 'groupId': 'OG001'}, {'value': '0.35', 'spread': '8.933', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.2579', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.14', 'ciLowerLimit': '-38.933', 'ciUpperLimit': '10.648', 'groupDescription': 'Mixed model for repeated measurements (MMRM) was used for evaluation. The model included the treatment group, visit and treatment-by-visit interaction as fixed effects, disease duration and baseline SALT I score as covariates.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'F-test'}, {'pValue': '0.0592', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.79', 'ciLowerLimit': '-44.446', 'ciUpperLimit': '0.871', 'groupDescription': 'MMRM was used for evaluation. The model included the treatment group, visit and treatment-by-visit interaction as fixed effects, disease duration and baseline SALT I score as covariates.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'F-test'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'DB Treatment Period: Baseline (before dose on Day 1), Week 24', 'description': 'SALT I is a well-validated metric used to determine the degree of hair loss based on the percentage (%) of scalp surface area involved on the top (40%), back (24%), left side (18%) and right side (18%) of the scalp for AA. Investigator determines the % scalp hair loss in a given quadrant, multiply this by the total scalp area delineated by that quadrant, and sum the resultant numbers for each quadrant to give the total % scalp hair loss with a maximum score of 100. Score range from 0% (no scalp hair loss) to 100% (complete scalp hair loss), higher scores indicated more scalp hair loss. Percent change from baseline in SALT I is reported in terms of Least square mean and standard error.', 'unitOfMeasure': 'Percent change of scalp surface area', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "DB treatment period's full analysis set (FAS) included all randomized participants with a SALT I less than (\\<) 95 at baseline who received at least one dose of study drug in DB treatment period. Participants were analyzed according to the treatment they received. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in SALT I at Week 24: DB Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Treatment Period: Etrasimod 2 mg', 'description': 'Participants who were randomized to receive etrasimod 2 milligram (mg) orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'DB Treatment Period: Etrasimod 3 mg', 'description': 'Participants who were randomized to receive etrasimod 2 mg orally once daily initially for Week 1 and then etrasimod 3 mg orally once daily for rest of the 23 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'DB Treatment Period: Placebo', 'description': 'Participants who were randomized to receive placebo matched to etrasimod orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.87', 'spread': '4.142', 'groupId': 'OG000'}, {'value': '-8.62', 'spread': '3.351', 'groupId': 'OG001'}, {'value': '0.36', 'spread': '4.314', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1283', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.23', 'ciLowerLimit': '-21.217', 'ciUpperLimit': '2.748', 'groupDescription': 'MMRM was used for evaluation. The model included the treatment group, visit and treatment-by-visit interaction as fixed effects, disease duration and baseline SALT I score as covariates.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'F-test'}, {'pValue': '0.1057', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.99', 'ciLowerLimit': '-19.936', 'ciUpperLimit': '1.962', 'groupDescription': 'MMRM was used for evaluation. The model included the treatment group, visit and treatment-by-visit interaction as fixed effects, disease duration and baseline SALT I score as covariates.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'F-test'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'DBT Period: Baseline, Week 24', 'description': 'SALT I is a well-validated metric used to determine the degree of hair loss based on the percentage (%) of scalp surface area involved on the top (40%), back (24%), left side (18%) and right side (18%) of the scalp for AA. Investigator determines the % scalp hair loss in a given quadrant, multiply this by the total scalp area delineated by that quadrant, and sum the resultant numbers for each quadrant to give the total % scalp hair loss with a maximum score of 100. Score range from 0% (no scalp hair loss) to 100% (complete scalp hair loss), higher scores indicated more scalp hair loss. Change from baseline in SALT I is reported in terms of Least square mean and standard error.', 'unitOfMeasure': '% of scalp surface area', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'DB treatment period\'s FAS included all randomized participants with a SALT I \\<95 at baseline who received at least one dose of study drug in DB treatment period. Participants were analyzed according to the treatment they received. Here, " Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Greater Than or Equal to (>=) 30%, >= 50% and >=75% Improvement From Baseline in SALT I at Week 24: DB Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Treatment Period: Etrasimod 2 mg', 'description': 'Participants who were randomized to receive etrasimod 2 milligram (mg) orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'DB Treatment Period: Etrasimod 3 mg', 'description': 'Participants who were randomized to receive etrasimod 2 mg orally once daily initially for Week 1 and then etrasimod 3 mg orally once daily for rest of the 23 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'DBT Period: Placebo', 'description': 'Participants received placebo matching to etrasimod orally once daily for 24 weeks in DBT period.'}], 'classes': [{'title': '>= 30% Improvement', 'categories': [{'measurements': [{'value': '23.5', 'groupId': 'OG000', 'lowerLimit': '6.81', 'upperLimit': '49.90'}, {'value': '36.0', 'groupId': 'OG001', 'lowerLimit': '17.97', 'upperLimit': '57.48'}, {'value': '12.5', 'groupId': 'OG002', 'lowerLimit': '1.55', 'upperLimit': '38.35'}]}]}, {'title': '>= 50% Improvement', 'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000', 'lowerLimit': '1.46', 'upperLimit': '36.44'}, {'value': '28.0', 'groupId': 'OG001', 'lowerLimit': '12.07', 'upperLimit': '49.39'}, {'value': '12.5', 'groupId': 'OG002', 'lowerLimit': '1.55', 'upperLimit': '38.35'}]}]}, {'title': '>= 75% Improvement', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '0.15', 'upperLimit': '28.69'}, {'value': '12.0', 'groupId': 'OG001', 'lowerLimit': '2.55', 'upperLimit': '31.22'}, {'value': '0.000', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '20.59'}]}]}], 'analyses': [{'pValue': '0.4067', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Response rate difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.5', 'ciLowerLimit': '-14.22', 'ciUpperLimit': '37.31', 'pValueComment': 'P-values were based on the comparison of etrasimod versus placebo.', 'estimateComment': 'Clopper-Pearson method', 'groupDescription': '\\>= 30% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 2 mg and DB Treatment period: Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.2171', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Response rate difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.5', 'ciLowerLimit': '-8.23', 'ciUpperLimit': '43.19', 'pValueComment': 'P-values were based on the comparison of etrasimod versus placebo.', 'estimateComment': 'Clopper-Pearson method', 'groupDescription': '\\>= 30% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 3 mg and DB Treatment period: Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.9425', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Response rate difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-23.18', 'ciUpperLimit': '21.48', 'pValueComment': 'P-values were based on the comparison of etrasimod versus placebo.', 'estimateComment': 'Clopper-Pearson method', 'groupDescription': '\\>= 50% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 2 mg and DB Treatment period: Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.4959', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Response rate difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.9', 'ciLowerLimit': '-15.19', 'ciUpperLimit': '32.94', 'pValueComment': 'P-values were based on the comparison of etrasimod versus placebo.', 'estimateComment': 'Clopper-Pearson method', 'groupDescription': '\\>= 50% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 3 mg and DB Treatment period: Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.3576', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Response rate difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.6', 'ciLowerLimit': '-5.39', 'ciUpperLimit': '16.59', 'pValueComment': 'P-values are based on the comparison of Etrasimod versus placebo.', 'estimateComment': 'Clopper-Pearson method', 'groupDescription': '\\>= 75% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 2 mg and DB Treatment period: Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.2904', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Response rate difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.3', 'ciLowerLimit': '-3.43', 'ciUpperLimit': '20.12', 'pValueComment': 'P-values were based on the comparison of etrasimod versus placebo.', 'estimateComment': 'Clopper-Pearson method', 'groupDescription': '\\>= 75% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 3 mg and DB Treatment period: Placebo.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'DB Treatment Period: Baseline, Week 24', 'description': 'SALT I is a well-validated metric used to determine the degree of hair loss based on the percentage of scalp surface area involved on the top, back, and each side of the scalp for alopecia areata (AA). Investigator determine the percent scalp hair loss in a given quadrant, multiply this by the total scalp area delineated by that quadrant, and sum the resultant numbers for each quadrant to give the total percent scalp hair loss with a maximum score of 100. Score range from 0 to 100, where 0 =no scalp hair loss to 100 = complete scalp hair loss, higher scores indicated more scalp hair loss. Percentage of participants who achieved \\>=30%, \\>=50%, \\>=75% improvement from baseline in SALT I at Week 24 was reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "DB treatment period's FAS included all randomized participants with a SALT I \\< 95 at baseline who received at least one dose of study drug in DB treatment period. Participants were analyzed according to the treatment they received. Missing data for any reason was imputed as per the non-responder imputation (NRI) method."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Adverse Events (AE): DB Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Treatment Period: Etrasimod 2 mg', 'description': 'Participants who were randomized to receive etrasimod 2 milligram (mg) orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'DB Treatment Period: Etrasimod 3 mg', 'description': 'Participants who were randomized to receive etrasimod 2 mg orally once daily initially for Week 1 and then etrasimod 3 mg orally once daily for rest of the 23 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'DB Treatment Period: Placebo', 'description': 'Participants who were randomized to receive placebo matched to etrasimod orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'DB Treatment Period: From first dosing date in DB up to (before the first dosing date in OLE) or (last dosing date + 4 weeks + 3 days), whichever is earlier (maximum up to 29 weeks)', 'description': 'An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations based on medical significance or any diagnosis of progressive multifocal leukoencephalopathy (PML). AEs included serious AEs and all non-SAEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "DB treatment period's SAF included of all randomized participants who received at least 1 dose of study drug in DBT period. Participants were analyzed according to the treatment they received."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Adverse Events: OLE Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'OLE Period: Etrasimod 2 mg [Etrasimod 2 mg in DB Treatment Period]', 'description': 'Participants who received etrasimod 2 mg in DB treatment period, received etrasimod 2 mg orally once daily in OLE period. Participants were followed up for up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'OLE Period: Etrasimod 2 mg [Placebo in DB Treatment Period]', 'description': 'Participants who received placebo matched to etrasimod in DB treatment period, received etrasimod 2 mg orally once daily in OLE period. Participants were followed up for up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'OLE Period: Etrasimod 3 mg [Etrasimod 3 mg in DBT]', 'description': 'Participants who received etrasimod 3 mg in DB treatment period, received etrasimod 3 mg orally once daily either from Week 25 to Week 52 or beginning after Week 25 to Week 52 in OLE period. Participants were followed up for up to 4 weeks after last dose of study drug.'}, {'id': 'OG003', 'title': 'OLE Period: Etrasimod 3 mg [Etrasimod 2 mg in DB Treatment Period]', 'description': 'Participants who received etrasimod 2 mg in DB treatment period, received etrasimod 3 mg orally once daily either from Week 25 to Week 52 or beginning after Week 25 to Week 52 in OLE period. Participants were followed up for up to 4 weeks after last dose of study drug.'}, {'id': 'OG004', 'title': 'OLE Period: Etrasimod 3 mg [Placebo in DB Treatment Period]', 'description': 'Participants received placebo matched to etrasimod in DB treatment period, received etrasimod 3 mg once daily either from Week 25 to Week 52 or beginning after Week 25 to Week 52 in OLE period.Participants were followed up for up to 4 weeks after last dose of study drug.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'OLE period: From first dosing date in OLE up to last dosing date + 4 weeks + 3 days (maximum up to 33 weeks)', 'description': 'An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations based on medical significance or any diagnosis of PML. AEs included serious AEs and all non-SAEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "OLE period's SAF included of all participants who received at least 1 dose of study drug in the OLE Period. Participants were analyzed according to the treatment they received."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DB Treatment Period: Etrasimod 2 mg', 'description': 'Participants who were randomized to receive etrasimod 2 milligram (mg) orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.'}, {'id': 'FG001', 'title': 'DB Treatment Period: Etrasimod 3 mg', 'description': 'Participants who were randomized to receive etrasimod 2 mg orally once daily initially for Week 1 and then etrasimod 3 mg orally once daily for rest of the 23 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.'}, {'id': 'FG002', 'title': 'DB Treatment Period: Placebo', 'description': 'Participants who were randomized to receive placebo matched to etrasimod orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.'}, {'id': 'FG003', 'title': 'OLE Period: Etrasimod 2 mg [Etrasimod 2 mg in DB Treatment Period]', 'description': 'Participants who received etrasimod 2 mg in DB treatment period, received etrasimod 2 mg orally once daily in OLE period. Participants were followed up for up to 4 weeks after last dose of study drug.'}, {'id': 'FG004', 'title': 'OLE Period: Etrasimod 2 mg [Placebo in DB Treatment Period]', 'description': 'Participants who received placebo matched to etrasimod in DB treatment period, received etrasimod 2 mg orally once daily in OLE period. Participants were followed up for up to 4 weeks after last dose of study drug.'}, {'id': 'FG005', 'title': 'OLE Period: Etrasimod 3 mg [Etrasimod 3 mg in DB Treatment Period]', 'description': 'Participants who received etrasimod 3 mg (also included participants whose dose was reduced from 3 mg to 2 mg due to safety issue) in DB treatment period, received etrasimod 3 mg orally once daily in OLE period either from Week 25 to Week 52 (participants who entered OLE phase on or after protocol amendment 2.0 and 2.1) or beginning after Week 25 to Week 52 in OLE period (participants who entered OLE before protocol amendment 2.0 and 2.1). Participants were followed up for up to 4 weeks after last dose of study drug.'}, {'id': 'FG006', 'title': 'OLE Period: Etrasimod 3 mg [Etrasimod 2 mg in DB Treatment Period]', 'description': 'Participants who received etrasimod 2 mg in DB treatment period, received etrasimod 3 mg orally once daily in OLE period either from Week 25 to Week 52 (participants who entered OLE phase on or after protocol amendment 2.0 and 2.1) or beginning after Week 25 to Week 52 in OLE period (participants who entered OLE before protocol amendment 2.0 and 2.1). Participants were followed up for up to 4 weeks after last dose of study drug.'}, {'id': 'FG007', 'title': 'OLE Period: Etrasimod 3 mg [Placebo in DB Treatment Period]', 'description': 'Participants received placebo matched to etrasimod in DB treatment period, received etrasimod 3 mg orally once daily in OLE period either from Week 25 to Week 52 (participants who entered OLE phase on or after protocol amendment 2.0 and 2.1) or beginning after Week 25 to Week 52 in OLE period (participants who entered OLE before protocol amendment 2.0 and 2.1). Participants were followed up for up to 4 weeks after last dose of study drug.'}], 'periods': [{'title': 'DB Treatment Period (24 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'comment': 'Completed Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}, {'title': 'OLE Period (28 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'comment': 'Participants who entered OLE period.', 'groupId': 'FG003', 'numSubjects': '4'}, {'comment': 'Participants who entered OLE period.', 'groupId': 'FG004', 'numSubjects': '4'}, {'comment': 'Participants who entered OLE period.', 'groupId': 'FG005', 'numSubjects': '24'}, {'comment': 'Participants who entered OLE period.', 'groupId': 'FG006', 'numSubjects': '20'}, {'comment': 'Participants who entered OLE period.', 'groupId': 'FG007', 'numSubjects': '13'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '24'}, {'groupId': 'FG006', 'numSubjects': '20'}, {'groupId': 'FG007', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'comment': 'Completed treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '21'}, {'groupId': 'FG006', 'numSubjects': '19'}, {'groupId': 'FG007', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Not reported', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study consisted of a double-blind (DB) treatment period (24 weeks) followed by an open label extension (OLE) period (28 weeks). A total of 80 participants with moderate-to-severe alopecia areata (AA) were enrolled in the DB treatment period of the study. Out of 80 participants, 65 participants entered in the subsequent OLE period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '20', 'groupId': 'BG006'}, {'value': '13', 'groupId': 'BG007'}, {'value': '145', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'DB Treatment Period: Etrasimod 2 mg', 'description': 'Participants who were randomized to receive etrasimod 2 milligram (mg) orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.'}, {'id': 'BG001', 'title': 'DB Treatment Period: Etrasimod 3 mg', 'description': 'Participants who were randomized to receive etrasimod 2 mg orally once daily initially for Week 1 and then etrasimod 3 mg orally once daily for rest of the 23 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.'}, {'id': 'BG002', 'title': 'DB Treatment Period: Placebo', 'description': 'Participants who were randomized to receive placebo matched to etrasimod orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.'}, {'id': 'BG003', 'title': 'OLE Period: Etrasimod 2 mg [Etrasimod 2 mg in DB Treatment Period]', 'description': 'Participants who received etrasimod 2 mg in DB treatment period, received etrasimod 2 mg orally once daily in OLE period. Participants were followed up for up to 4 weeks after last dose of study drug.'}, {'id': 'BG004', 'title': 'OLE Period: Etrasimod 2 mg [Placebo in DB Treatment Period]', 'description': 'Participants who received placebo matched to etrasimod in DB treatment period, received etrasimod 2 mg orally once daily in OLE period. Participants were followed up for up to 4 weeks after last dose of study drug.'}, {'id': 'BG005', 'title': 'OLE Period: Etrasimod 3 mg [Etrasimod 3 mg in DB Treatment Period]', 'description': 'Participants who received etrasimod 3 mg (also included participants whose dose was reduced from 3 mg to 2 mg due to safety issue) in DB treatment period, received etrasimod 3 mg orally once daily in OLE period either from Week 25 to Week 52 (participants who entered OLE phase on or after protocol amendment 2.0 and 2.1) or beginning after Week 25 to Week 52 in OLE period (participants who entered OLE before protocol amendment 2.0 and 2.1). Participants were followed up for up to 4 weeks after last dose of study drug.'}, {'id': 'BG006', 'title': 'OLE Period: Etrasimod 3 mg [Etrasimod 2 mg in DB Treatment Period]', 'description': 'Participants who received etrasimod 2 mg in DB treatment period, received etrasimod 3 mg orally once daily in OLE period either from Week 25 to Week 52 (participants who entered OLE phase on or after protocol amendment 2.0 and 2.1) or beginning after Week 25 to Week 52 in OLE period (participants who entered OLE before protocol amendment 2.0 and 2.1). Participants were followed up for up to 4 weeks after last dose of study drug.'}, {'id': 'BG007', 'title': 'OLE Period: Etrasimod 3 mg [Placebo in DB Treatment Period]', 'description': 'Participants received placebo matched to etrasimod in DB treatment period, received etrasimod 3 mg orally once daily in OLE period either from Week 25 to Week 52 (participants who entered OLE phase on or after protocol amendment 2.0 and 2.1) or beginning after Week 25 to Week 52 in OLE period (participants who entered OLE before protocol amendment 2.0 and 2.1). Participants were followed up for up to 4 weeks after last dose of study drug.'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'DB Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '80', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '36.6', 'spread': '12.60', 'groupId': 'BG000'}, {'value': '41.7', 'spread': '16.63', 'groupId': 'BG001'}, {'value': '43.4', 'spread': '13.25', 'groupId': 'BG002'}, {'value': '40.4', 'spread': '14.33', 'groupId': 'BG008'}]}]}, {'title': 'OLE Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '20', 'groupId': 'BG006'}, {'value': '13', 'groupId': 'BG007'}, {'value': '65', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '38.0', 'spread': '14.99', 'groupId': 'BG003'}, {'value': '43.5', 'spread': '15.67', 'groupId': 'BG004'}, {'value': '42.4', 'spread': '16.65', 'groupId': 'BG005'}, {'value': '35.1', 'spread': '12.17', 'groupId': 'BG006'}, {'value': '44.8', 'spread': '11.53', 'groupId': 'BG007'}, {'value': '40.4', 'spread': '14.35', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'DB Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '80', 'groupId': 'BG008'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '59', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '21', 'groupId': 'BG008'}]}]}, {'title': 'OLE Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '20', 'groupId': 'BG006'}, {'value': '13', 'groupId': 'BG007'}, {'value': '65', 'groupId': 'BG008'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}, {'value': '13', 'groupId': 'BG007'}, {'value': '46', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '19', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'DB Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '80', 'groupId': 'BG008'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '10', 'groupId': 'BG008'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '66', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}]}]}, {'title': 'OLE Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '20', 'groupId': 'BG006'}, {'value': '13', 'groupId': 'BG007'}, {'value': '65', 'groupId': 'BG008'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '7', 'groupId': 'BG008'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '21', 'groupId': 'BG005'}, {'value': '14', 'groupId': 'BG006'}, {'value': '12', 'groupId': 'BG007'}, {'value': '55', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'DB Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '80', 'groupId': 'BG008'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '11', 'groupId': 'BG008'}]}, {'title': 'White', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '58', 'groupId': 'BG008'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}]}]}, {'title': 'OLE Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '20', 'groupId': 'BG006'}, {'value': '13', 'groupId': 'BG007'}, {'value': '65', 'groupId': 'BG008'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '10', 'groupId': 'BG008'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}, {'value': '16', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '44', 'groupId': 'BG008'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.'}], 'populationDescription': 'DB Treatment Period randomized set included all randomized participants, irrespective of whether they received any study drug. OLE Safety set (SAF) included all participants who received at least 1 dose of study drug. Participants in DB treatment period and OLE period are not exclusive. Eligible participants from DB treatment period entered OLE period after completing treatment in DB treatment period.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-25', 'size': 813746, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-05-30T12:05', 'hasProtocol': True}, {'date': '2023-02-22', 'size': 8331529, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-05-30T12:05', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double-Blind, Placebo-Controlled'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-30', 'studyFirstSubmitDate': '2020-09-15', 'resultsFirstSubmitDate': '2024-05-30', 'studyFirstSubmitQcDate': '2020-09-15', 'lastUpdatePostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-30', 'studyFirstPostDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Adverse Events (AE): DB Treatment Period', 'timeFrame': 'DB Treatment Period: From first dosing date in DB up to (before the first dosing date in OLE) or (last dosing date + 4 weeks + 3 days), whichever is earlier (maximum up to 29 weeks)', 'description': 'An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations based on medical significance or any diagnosis of progressive multifocal leukoencephalopathy (PML). AEs included serious AEs and all non-SAEs.'}, {'measure': 'Number of Participants With Adverse Events: OLE Period', 'timeFrame': 'OLE period: From first dosing date in OLE up to last dosing date + 4 weeks + 3 days (maximum up to 33 weeks)', 'description': 'An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations based on medical significance or any diagnosis of PML. AEs included serious AEs and all non-SAEs.'}], 'primaryOutcomes': [{'measure': 'Percent Change From Baseline in Severity of Alopecia Tool I (SALT I) at Week 24: DB Treatment Period', 'timeFrame': 'DB Treatment Period: Baseline (before dose on Day 1), Week 24', 'description': 'SALT I is a well-validated metric used to determine the degree of hair loss based on the percentage (%) of scalp surface area involved on the top (40%), back (24%), left side (18%) and right side (18%) of the scalp for AA. Investigator determines the % scalp hair loss in a given quadrant, multiply this by the total scalp area delineated by that quadrant, and sum the resultant numbers for each quadrant to give the total % scalp hair loss with a maximum score of 100. Score range from 0% (no scalp hair loss) to 100% (complete scalp hair loss), higher scores indicated more scalp hair loss. Percent change from baseline in SALT I is reported in terms of Least square mean and standard error.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in SALT I at Week 24: DB Treatment Period', 'timeFrame': 'DBT Period: Baseline, Week 24', 'description': 'SALT I is a well-validated metric used to determine the degree of hair loss based on the percentage (%) of scalp surface area involved on the top (40%), back (24%), left side (18%) and right side (18%) of the scalp for AA. Investigator determines the % scalp hair loss in a given quadrant, multiply this by the total scalp area delineated by that quadrant, and sum the resultant numbers for each quadrant to give the total % scalp hair loss with a maximum score of 100. Score range from 0% (no scalp hair loss) to 100% (complete scalp hair loss), higher scores indicated more scalp hair loss. Change from baseline in SALT I is reported in terms of Least square mean and standard error.'}, {'measure': 'Percentage of Participants Who Achieved Greater Than or Equal to (>=) 30%, >= 50% and >=75% Improvement From Baseline in SALT I at Week 24: DB Treatment Period', 'timeFrame': 'DB Treatment Period: Baseline, Week 24', 'description': 'SALT I is a well-validated metric used to determine the degree of hair loss based on the percentage of scalp surface area involved on the top, back, and each side of the scalp for alopecia areata (AA). Investigator determine the percent scalp hair loss in a given quadrant, multiply this by the total scalp area delineated by that quadrant, and sum the resultant numbers for each quadrant to give the total percent scalp hair loss with a maximum score of 100. Score range from 0 to 100, where 0 =no scalp hair loss to 100 = complete scalp hair loss, higher scores indicated more scalp hair loss. Percentage of participants who achieved \\>=30%, \\>=50%, \\>=75% improvement from baseline in SALT I at Week 24 was reported in this outcome measure.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['T-cell-mediated autoimmune skin disorder', 'Alopecia areata', 'Alopecia', 'APD334', 'Etrasimod', 'Hair loss'], 'conditions': ['Alopecia Areata']}, 'referencesModule': {'references': [{'pmid': '40145547', 'type': 'DERIVED', 'citation': 'King B, Mesinkovska N, Senna M, Luo X, Minkiewicz J, Selfridge A. Efficacy and safety of etrasimod in alopecia areata: A multicentre, randomized, double-blind, placebo-controlled, Phase 2 study. J Eur Acad Dermatol Venereol. 2025 Jun;39(6):1174-1184. doi: 10.1111/jdv.20605. Epub 2025 Mar 27.'}, {'pmid': '39575597', 'type': 'DERIVED', 'citation': 'Dubinsky MC, Wu J, McDonnell A, Lazin K, Goetsch M, Branquinho D, Modesto I, Armuzzi A. Low Incidence of Macular Edema and Other Ocular Events in the Etrasimod Development Program. J Crohns Colitis. 2025 May 8;19(5):jjae173. doi: 10.1093/ecco-jcc/jjae173.'}], 'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=APD334-205', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of etrasimod monotherapy (2 milligrams \\[mg\\] and 3 mg) in participants with moderate-to-severe alopecia areata (AA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Men or women between ≥18 and ≤70 years of age at the time of informed consent\n* Moderate-to-severe alopecia areata as assessed by a SALT score of ≥25 and \\<95 at Screening and Day 1/Baseline.\n* Current episode of hair loss for ≥6 months but \\<5 years\n* Stable disease condition (no significant growth of hair) in the last 6 months as assessed by the Investigator\n* Willing to keep the same hair style and color (eg, hair products, process, and timing for hair appointments) for the duration of the study\n\nKey Exclusion Criteria:\n\n* History of male or female pattern hair loss \\>Hamilton stage III or \\>Ludwig stage II\n* Other types of alopecia (eg, cicatricial/scarring alopecia \\[including central centrifugal cicatricial alopecia\\], traction alopecia, or telogen effluvium) or other diseases that could cause hair loss\n* Active scalp inflammation, scalp infection, scalp psoriasis, or any other scalp condition that may interfere with the SALT assessment\n* Previous use of Janus kinase (JAK) inhibitor (oral or topical), including participation in clinical studies of JAK inhibitors'}, 'identificationModule': {'nctId': 'NCT04556734', 'briefTitle': 'Safety and Efficacy of Oral Etrasimod in Adult Participants With Moderate-to-Severe Alopecia Areata', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 24-Week Study, With a 28-Week Open-Label Extension, to Assess the Safety and Efficacy of Etrasimod in Subjects With Moderate-to-Severe Alopecia Areata', 'orgStudyIdInfo': {'id': 'APD334-205'}, 'secondaryIdInfos': [{'id': 'C5041008', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Etrasimod 2 mg', 'interventionNames': ['Drug: Etrasimod']}, {'type': 'EXPERIMENTAL', 'label': 'Etrasimod 3 mg', 'interventionNames': ['Drug: Etrasimod']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Etrasimod', 'type': 'DRUG', 'otherNames': ['APD334'], 'description': 'Etrasimod 2 mg tablet by mouth, once daily', 'armGroupLabels': ['Etrasimod 2 mg']}, {'name': 'Etrasimod', 'type': 'DRUG', 'otherNames': ['APD334'], 'description': 'Etrasimod 3 mg 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